Enhancing the regulatory decision-making approval process for direct food ingredient technologies :: workshop summary /
Gespeichert in:
| Körperschaft: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Washington, D.C. :
National Academy Press,
1999.
|
| Schriftenreihe: | Compass series (Washington, D.C.)
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Beschreibung: | Based on a workshop convened by the Food Forum, May 6-7, 1997. |
| Beschreibung: | 1 online resource (vii, 150 pages) |
| Bibliographie: | Includes bibliographical references. |
| ISBN: | 058505780X 9780585057804 |
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| 245 | 0 | 0 | |a Enhancing the regulatory decision-making approval process for direct food ingredient technologies : |b workshop summary / |c Food Forum, Food and Nutrition Board, Institute of Medicine. |
| 260 | |a Washington, D.C. : |b National Academy Press, |c 1999. | ||
| 300 | |a 1 online resource (vii, 150 pages) | ||
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| 500 | |a Based on a workshop convened by the Food Forum, May 6-7, 1997. | ||
| 504 | |a Includes bibliographical references. | ||
| 588 | 0 | |a Print version record. | |
| 505 | 0 | |a Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies -- Copyright -- PREFACE -- Contents -- WORKSHOP SUMMARY -- INTRODUCTION AND BACKGROUND -- OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES -- Food Additives -- GRAS SUBSTANCES -- Interim Additives -- LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS -- Flaws of the Current Review Process -- Proposed Changes in the Approval Process -- Change or Enforce Deadlines for Petition Reviews -- Implement User Fees -- Grant a Period of Market Exclusivity -- Re-evaluate GRAS Affirmation Process -- Eliminate Notice-and-Comment Procedures -- Abbreviate Review for Supplemental Uses -- Evaluate Use of Extramural Petition Review -- Prioritize Reviews -- Implement Safeguards to Prevent Sham Petitioning -- Establish a Sunset Period for Interim Additives -- Foster Improved Communication between Industry and FDA -- Improve Quality of Petitions Submitted to FDA -- SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS -- CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY -- CURRENT EFFORTS -- International Efforts -- IMPROVING THE REGULATORY REVIEW PROCESS -- Government Perspective -- Industry Perspective -- Consumer Perspective -- SUMMARY -- APPENDIX A Legal Aspects of the Food Additive Approval Process -- HISTORY -- The Food, Drug, and Cosmetic Act of 1938 -- The Food Additives Amendment of 1958 -- DEFINITION OF FOOD ADDITIVE -- Components of Food -- Indirect Additives -- Dietary Supplements -- Generally Recognized as Safe -- APPROVAL PROCEDURES -- Food Additive Petitions -- GRAS Affirmation Petitions -- Interim Food Additives -- SAFETY STANDARDS -- General Safety Standard -- Carcinogenicity and the Delaney Clause -- Special Restrictions: Labeling -- CASE STUDIES -- Artificial Sweeteners: Aspartame -- Biotechnology: Calgene's Tomato -- Novel Macroingredients: Olestra. | |
| 505 | 8 | |a THE COMPOSITE PICTURE -- Track Records Compared -- A Catalogue of Proposed Solutions -- Internal Management Initiatives -- Statutory Hammers -- Prioritizing Reviews -- Imposing User Fees -- Extramural Reviews -- Combatting Sham Petitioning -- CONCLUSION -- APPENDIX: INTERNATIONAL COMPARISONS -- Canada -- The United Kingdom -- The European Union -- Japan -- REFERENCES -- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug,... -- TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES -- Introduction -- Developments in Analytical Chemistry -- Developments in Toxicology -- The Emerging Understanding of Mechanisms -- Changes in Risk and Safety Assessment -- Changes in Agriculture -- Environmental Concerns -- Consumer Activity -- Changes in Food Marketing and Consumption Trends -- The Impact on FDA -- Provisions That Continue to Work Well after Six Decades -- Conclusion -- CYCLAMATE -- Overview -- Chronology -- Comments -- Lessons Learned -- IRRADIATED POULTRY -- Overview -- Chronology -- Comments -- Lessons Learned -- OLESTRA -- Overview -- Chronology -- Lessons Learned -- FD& -- C RED NO. 2 (AMARANTH) -- Overview -- Chronology -- Comment -- Lessons Learned -- FD& -- C RED NO. 3 (ERYTHROSINE) -- Overview -- Chronology -- Comments -- Lessons Learned -- TCE AND DCM -- Overview -- Chronology -- Comments -- Lessons Learned -- D-LIMONENE -- Overview -- Chronology -- Lessons Learned -- BENZYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- ISO-AMYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- FURFURAL -- Overview -- Chronology -- Comments -- Lessons Learned -- PULSED LIGHT -- Overview -- Chronology -- Lessons Learned -- CHYMOSIN -- Overview -- Chronology -- Comment -- Lessons Learned. | |
| 505 | 8 | |a APPENDIX C Enhancing the Regulatory Approval Process for Food Ingredient Technologies A Workshop -- WORKSHOP AGENDA -- APPENDIX D Enhancing the Regulatory Approval Process for Food Ingredient Technologies -- PARTICIPANTS LIST -- ACRONYMS. | |
| 650 | 0 | |a Food additives |z United States |v Congresses. | |
| 650 | 0 | |a Food additives |x Safety regulations |z United States |v Congresses. | |
| 650 | 0 | |a Food additives. |0 http://id.loc.gov/authorities/subjects/sh85050253 | |
| 650 | 0 | |a Food law and legislation. |0 http://id.loc.gov/authorities/subjects/sh85050300 | |
| 650 | 1 | 2 | |a Food Additives |
| 650 | 1 | 2 | |a Legislation, Food |
| 651 | 2 | |a United States | |
| 650 | 6 | |a Aliments |x Additifs |z États-Unis |v Congrès. | |
| 650 | 6 | |a Aliments |x Additifs |v Sécurité |x Règlements |z États-Unis |v Congrès. | |
| 650 | 6 | |a Aliments |x Additifs |x Sécurité |x Règlements |z États-Unis |v Congrès. | |
| 650 | 6 | |a Aliments |x Additifs. | |
| 650 | 6 | |a Aliments |x Droit |v Législation. | |
| 650 | 7 | |a HEALTH & FITNESS |x Safety. |2 bisacsh | |
| 650 | 7 | |a Food law and legislation |2 fast | |
| 650 | 7 | |a Food additives |2 fast | |
| 650 | 7 | |a Food additives |x Safety regulations |2 fast | |
| 651 | 7 | |a United States |2 fast |1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq | |
| 655 | 7 | |a Conference papers and proceedings |2 fast | |
| 710 | 2 | |a Institute of Medicine (U.S.). |b Food Forum. |0 http://id.loc.gov/authorities/names/no99071005 | |
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| contents | Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies -- Copyright -- PREFACE -- Contents -- WORKSHOP SUMMARY -- INTRODUCTION AND BACKGROUND -- OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES -- Food Additives -- GRAS SUBSTANCES -- Interim Additives -- LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS -- Flaws of the Current Review Process -- Proposed Changes in the Approval Process -- Change or Enforce Deadlines for Petition Reviews -- Implement User Fees -- Grant a Period of Market Exclusivity -- Re-evaluate GRAS Affirmation Process -- Eliminate Notice-and-Comment Procedures -- Abbreviate Review for Supplemental Uses -- Evaluate Use of Extramural Petition Review -- Prioritize Reviews -- Implement Safeguards to Prevent Sham Petitioning -- Establish a Sunset Period for Interim Additives -- Foster Improved Communication between Industry and FDA -- Improve Quality of Petitions Submitted to FDA -- SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS -- CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY -- CURRENT EFFORTS -- International Efforts -- IMPROVING THE REGULATORY REVIEW PROCESS -- Government Perspective -- Industry Perspective -- Consumer Perspective -- SUMMARY -- APPENDIX A Legal Aspects of the Food Additive Approval Process -- HISTORY -- The Food, Drug, and Cosmetic Act of 1938 -- The Food Additives Amendment of 1958 -- DEFINITION OF FOOD ADDITIVE -- Components of Food -- Indirect Additives -- Dietary Supplements -- Generally Recognized as Safe -- APPROVAL PROCEDURES -- Food Additive Petitions -- GRAS Affirmation Petitions -- Interim Food Additives -- SAFETY STANDARDS -- General Safety Standard -- Carcinogenicity and the Delaney Clause -- Special Restrictions: Labeling -- CASE STUDIES -- Artificial Sweeteners: Aspartame -- Biotechnology: Calgene's Tomato -- Novel Macroingredients: Olestra. THE COMPOSITE PICTURE -- Track Records Compared -- A Catalogue of Proposed Solutions -- Internal Management Initiatives -- Statutory Hammers -- Prioritizing Reviews -- Imposing User Fees -- Extramural Reviews -- Combatting Sham Petitioning -- CONCLUSION -- APPENDIX: INTERNATIONAL COMPARISONS -- Canada -- The United Kingdom -- The European Union -- Japan -- REFERENCES -- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug,... -- TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES -- Introduction -- Developments in Analytical Chemistry -- Developments in Toxicology -- The Emerging Understanding of Mechanisms -- Changes in Risk and Safety Assessment -- Changes in Agriculture -- Environmental Concerns -- Consumer Activity -- Changes in Food Marketing and Consumption Trends -- The Impact on FDA -- Provisions That Continue to Work Well after Six Decades -- Conclusion -- CYCLAMATE -- Overview -- Chronology -- Comments -- Lessons Learned -- IRRADIATED POULTRY -- Overview -- Chronology -- Comments -- Lessons Learned -- OLESTRA -- Overview -- Chronology -- Lessons Learned -- FD& -- C RED NO. 2 (AMARANTH) -- Overview -- Chronology -- Comment -- Lessons Learned -- FD& -- C RED NO. 3 (ERYTHROSINE) -- Overview -- Chronology -- Comments -- Lessons Learned -- TCE AND DCM -- Overview -- Chronology -- Comments -- Lessons Learned -- D-LIMONENE -- Overview -- Chronology -- Lessons Learned -- BENZYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- ISO-AMYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- FURFURAL -- Overview -- Chronology -- Comments -- Lessons Learned -- PULSED LIGHT -- Overview -- Chronology -- Lessons Learned -- CHYMOSIN -- Overview -- Chronology -- Comment -- Lessons Learned. APPENDIX C Enhancing the Regulatory Approval Process for Food Ingredient Technologies A Workshop -- WORKSHOP AGENDA -- APPENDIX D Enhancing the Regulatory Approval Process for Food Ingredient Technologies -- PARTICIPANTS LIST -- ACRONYMS. |
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INTRODUCTION AND BACKGROUND -- OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES -- Food Additives -- GRAS SUBSTANCES -- Interim Additives -- LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS -- Flaws of the Current Review Process -- Proposed Changes in the Approval Process -- Change or Enforce Deadlines for Petition Reviews -- Implement User Fees -- Grant a Period of Market Exclusivity -- Re-evaluate GRAS Affirmation Process -- Eliminate Notice-and-Comment Procedures -- Abbreviate Review for Supplemental Uses -- Evaluate Use of Extramural Petition Review -- Prioritize Reviews -- Implement Safeguards to Prevent Sham Petitioning -- Establish a Sunset Period for Interim Additives -- Foster Improved Communication between Industry and FDA -- Improve Quality of Petitions Submitted to FDA -- SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS -- CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY -- CURRENT EFFORTS -- International Efforts -- IMPROVING THE REGULATORY REVIEW PROCESS -- Government Perspective -- Industry Perspective -- Consumer Perspective -- SUMMARY -- APPENDIX A Legal Aspects of the Food Additive Approval Process -- HISTORY -- The Food, Drug, and Cosmetic Act of 1938 -- The Food Additives Amendment of 1958 -- DEFINITION OF FOOD ADDITIVE -- Components of Food -- Indirect Additives -- Dietary Supplements -- Generally Recognized as Safe -- APPROVAL PROCEDURES -- Food Additive Petitions -- GRAS Affirmation Petitions -- Interim Food Additives -- SAFETY STANDARDS -- General Safety Standard -- Carcinogenicity and the Delaney Clause -- Special Restrictions: Labeling -- CASE STUDIES -- Artificial Sweeteners: Aspartame -- Biotechnology: Calgene's Tomato -- Novel Macroingredients: Olestra.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">THE COMPOSITE PICTURE -- Track Records Compared -- A Catalogue of Proposed Solutions -- Internal Management Initiatives -- Statutory Hammers -- Prioritizing Reviews -- Imposing User Fees -- Extramural Reviews -- Combatting Sham Petitioning -- CONCLUSION -- APPENDIX: INTERNATIONAL COMPARISONS -- Canada -- The United Kingdom -- The European Union -- Japan -- REFERENCES -- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug,... -- TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES -- Introduction -- Developments in Analytical Chemistry -- Developments in Toxicology -- The Emerging Understanding of Mechanisms -- Changes in Risk and Safety Assessment -- Changes in Agriculture -- Environmental Concerns -- Consumer Activity -- Changes in Food Marketing and Consumption Trends -- The Impact on FDA -- Provisions That Continue to Work Well after Six Decades -- Conclusion -- CYCLAMATE -- Overview -- Chronology -- Comments -- Lessons Learned -- IRRADIATED POULTRY -- Overview -- Chronology -- Comments -- Lessons Learned -- OLESTRA -- Overview -- Chronology -- Lessons Learned -- FD&amp -- C RED NO. 2 (AMARANTH) -- Overview -- Chronology -- Comment -- Lessons Learned -- FD&amp -- C RED NO. 3 (ERYTHROSINE) -- Overview -- Chronology -- Comments -- Lessons Learned -- TCE AND DCM -- Overview -- Chronology -- Comments -- Lessons Learned -- D-LIMONENE -- Overview -- Chronology -- Lessons Learned -- BENZYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- ISO-AMYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- FURFURAL -- Overview -- Chronology -- Comments -- Lessons Learned -- PULSED LIGHT -- Overview -- Chronology -- Lessons Learned -- CHYMOSIN -- Overview -- Chronology -- Comment -- Lessons Learned.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">APPENDIX C Enhancing the Regulatory Approval Process for Food Ingredient Technologies A Workshop -- WORKSHOP AGENDA -- APPENDIX D Enhancing the Regulatory Approval Process for Food Ingredient Technologies -- PARTICIPANTS LIST -- 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| genre | Conference papers and proceedings fast |
| genre_facet | Conference papers and proceedings |
| geographic | United States United States fast https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq |
| geographic_facet | United States |
| id | ZDB-4-EBA-ocm44957865 |
| illustrated | Not Illustrated |
| indexdate | 2024-11-27T13:15:03Z |
| institution | BVB |
| institution_GND | http://id.loc.gov/authorities/names/no99071005 |
| isbn | 058505780X 9780585057804 |
| language | English |
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| publishDate | 1999 |
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| spelling | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / Food Forum, Food and Nutrition Board, Institute of Medicine. Washington, D.C. : National Academy Press, 1999. 1 online resource (vii, 150 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier data file Compass series Based on a workshop convened by the Food Forum, May 6-7, 1997. Includes bibliographical references. Print version record. Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies -- Copyright -- PREFACE -- Contents -- WORKSHOP SUMMARY -- INTRODUCTION AND BACKGROUND -- OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES -- Food Additives -- GRAS SUBSTANCES -- Interim Additives -- LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS -- Flaws of the Current Review Process -- Proposed Changes in the Approval Process -- Change or Enforce Deadlines for Petition Reviews -- Implement User Fees -- Grant a Period of Market Exclusivity -- Re-evaluate GRAS Affirmation Process -- Eliminate Notice-and-Comment Procedures -- Abbreviate Review for Supplemental Uses -- Evaluate Use of Extramural Petition Review -- Prioritize Reviews -- Implement Safeguards to Prevent Sham Petitioning -- Establish a Sunset Period for Interim Additives -- Foster Improved Communication between Industry and FDA -- Improve Quality of Petitions Submitted to FDA -- SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS -- CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY -- CURRENT EFFORTS -- International Efforts -- IMPROVING THE REGULATORY REVIEW PROCESS -- Government Perspective -- Industry Perspective -- Consumer Perspective -- SUMMARY -- APPENDIX A Legal Aspects of the Food Additive Approval Process -- HISTORY -- The Food, Drug, and Cosmetic Act of 1938 -- The Food Additives Amendment of 1958 -- DEFINITION OF FOOD ADDITIVE -- Components of Food -- Indirect Additives -- Dietary Supplements -- Generally Recognized as Safe -- APPROVAL PROCEDURES -- Food Additive Petitions -- GRAS Affirmation Petitions -- Interim Food Additives -- SAFETY STANDARDS -- General Safety Standard -- Carcinogenicity and the Delaney Clause -- Special Restrictions: Labeling -- CASE STUDIES -- Artificial Sweeteners: Aspartame -- Biotechnology: Calgene's Tomato -- Novel Macroingredients: Olestra. THE COMPOSITE PICTURE -- Track Records Compared -- A Catalogue of Proposed Solutions -- Internal Management Initiatives -- Statutory Hammers -- Prioritizing Reviews -- Imposing User Fees -- Extramural Reviews -- Combatting Sham Petitioning -- CONCLUSION -- APPENDIX: INTERNATIONAL COMPARISONS -- Canada -- The United Kingdom -- The European Union -- Japan -- REFERENCES -- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug,... -- TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES -- Introduction -- Developments in Analytical Chemistry -- Developments in Toxicology -- The Emerging Understanding of Mechanisms -- Changes in Risk and Safety Assessment -- Changes in Agriculture -- Environmental Concerns -- Consumer Activity -- Changes in Food Marketing and Consumption Trends -- The Impact on FDA -- Provisions That Continue to Work Well after Six Decades -- Conclusion -- CYCLAMATE -- Overview -- Chronology -- Comments -- Lessons Learned -- IRRADIATED POULTRY -- Overview -- Chronology -- Comments -- Lessons Learned -- OLESTRA -- Overview -- Chronology -- Lessons Learned -- FD& -- C RED NO. 2 (AMARANTH) -- Overview -- Chronology -- Comment -- Lessons Learned -- FD& -- C RED NO. 3 (ERYTHROSINE) -- Overview -- Chronology -- Comments -- Lessons Learned -- TCE AND DCM -- Overview -- Chronology -- Comments -- Lessons Learned -- D-LIMONENE -- Overview -- Chronology -- Lessons Learned -- BENZYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- ISO-AMYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- FURFURAL -- Overview -- Chronology -- Comments -- Lessons Learned -- PULSED LIGHT -- Overview -- Chronology -- Lessons Learned -- CHYMOSIN -- Overview -- Chronology -- Comment -- Lessons Learned. APPENDIX C Enhancing the Regulatory Approval Process for Food Ingredient Technologies A Workshop -- WORKSHOP AGENDA -- APPENDIX D Enhancing the Regulatory Approval Process for Food Ingredient Technologies -- PARTICIPANTS LIST -- ACRONYMS. Food additives United States Congresses. Food additives Safety regulations United States Congresses. Food additives. http://id.loc.gov/authorities/subjects/sh85050253 Food law and legislation. http://id.loc.gov/authorities/subjects/sh85050300 Food Additives Legislation, Food United States Aliments Additifs États-Unis Congrès. Aliments Additifs Sécurité Règlements États-Unis Congrès. Aliments Additifs. Aliments Droit Législation. HEALTH & FITNESS Safety. bisacsh Food law and legislation fast Food additives fast Food additives Safety regulations fast United States fast https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq Conference papers and proceedings fast Institute of Medicine (U.S.). Food Forum. http://id.loc.gov/authorities/names/no99071005 has work: Enhancing the Regulatory Decision-making Approval Process for Direct Food Ingredient Technologies: Workshop Summary (Text) https://id.oclc.org/worldcat/entity/E39PD3PWwCV6hYbFYQMpkDvfYK https://id.oclc.org/worldcat/ontology/hasWork Print version: Enhancing the regulatory decision-making approval process for direct food ingredient technologies. Washington, D.C. : National Academy Press, 1999 0309064864 (DLC) 99062305 (OCoLC)41390482 Compass series (Washington, D.C.) http://id.loc.gov/authorities/names/n97013362 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=8719 Volltext |
| spellingShingle | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / Compass series (Washington, D.C.) Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies -- Copyright -- PREFACE -- Contents -- WORKSHOP SUMMARY -- INTRODUCTION AND BACKGROUND -- OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES -- Food Additives -- GRAS SUBSTANCES -- Interim Additives -- LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS -- Flaws of the Current Review Process -- Proposed Changes in the Approval Process -- Change or Enforce Deadlines for Petition Reviews -- Implement User Fees -- Grant a Period of Market Exclusivity -- Re-evaluate GRAS Affirmation Process -- Eliminate Notice-and-Comment Procedures -- Abbreviate Review for Supplemental Uses -- Evaluate Use of Extramural Petition Review -- Prioritize Reviews -- Implement Safeguards to Prevent Sham Petitioning -- Establish a Sunset Period for Interim Additives -- Foster Improved Communication between Industry and FDA -- Improve Quality of Petitions Submitted to FDA -- SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS -- CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY -- CURRENT EFFORTS -- International Efforts -- IMPROVING THE REGULATORY REVIEW PROCESS -- Government Perspective -- Industry Perspective -- Consumer Perspective -- SUMMARY -- APPENDIX A Legal Aspects of the Food Additive Approval Process -- HISTORY -- The Food, Drug, and Cosmetic Act of 1938 -- The Food Additives Amendment of 1958 -- DEFINITION OF FOOD ADDITIVE -- Components of Food -- Indirect Additives -- Dietary Supplements -- Generally Recognized as Safe -- APPROVAL PROCEDURES -- Food Additive Petitions -- GRAS Affirmation Petitions -- Interim Food Additives -- SAFETY STANDARDS -- General Safety Standard -- Carcinogenicity and the Delaney Clause -- Special Restrictions: Labeling -- CASE STUDIES -- Artificial Sweeteners: Aspartame -- Biotechnology: Calgene's Tomato -- Novel Macroingredients: Olestra. THE COMPOSITE PICTURE -- Track Records Compared -- A Catalogue of Proposed Solutions -- Internal Management Initiatives -- Statutory Hammers -- Prioritizing Reviews -- Imposing User Fees -- Extramural Reviews -- Combatting Sham Petitioning -- CONCLUSION -- APPENDIX: INTERNATIONAL COMPARISONS -- Canada -- The United Kingdom -- The European Union -- Japan -- REFERENCES -- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug,... -- TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES -- Introduction -- Developments in Analytical Chemistry -- Developments in Toxicology -- The Emerging Understanding of Mechanisms -- Changes in Risk and Safety Assessment -- Changes in Agriculture -- Environmental Concerns -- Consumer Activity -- Changes in Food Marketing and Consumption Trends -- The Impact on FDA -- Provisions That Continue to Work Well after Six Decades -- Conclusion -- CYCLAMATE -- Overview -- Chronology -- Comments -- Lessons Learned -- IRRADIATED POULTRY -- Overview -- Chronology -- Comments -- Lessons Learned -- OLESTRA -- Overview -- Chronology -- Lessons Learned -- FD& -- C RED NO. 2 (AMARANTH) -- Overview -- Chronology -- Comment -- Lessons Learned -- FD& -- C RED NO. 3 (ERYTHROSINE) -- Overview -- Chronology -- Comments -- Lessons Learned -- TCE AND DCM -- Overview -- Chronology -- Comments -- Lessons Learned -- D-LIMONENE -- Overview -- Chronology -- Lessons Learned -- BENZYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- ISO-AMYL ACETATE -- Overview -- Chronology -- Comments -- Lessons Learned -- FURFURAL -- Overview -- Chronology -- Comments -- Lessons Learned -- PULSED LIGHT -- Overview -- Chronology -- Lessons Learned -- CHYMOSIN -- Overview -- Chronology -- Comment -- Lessons Learned. APPENDIX C Enhancing the Regulatory Approval Process for Food Ingredient Technologies A Workshop -- WORKSHOP AGENDA -- APPENDIX D Enhancing the Regulatory Approval Process for Food Ingredient Technologies -- PARTICIPANTS LIST -- ACRONYMS. Food additives United States Congresses. Food additives Safety regulations United States Congresses. Food additives. http://id.loc.gov/authorities/subjects/sh85050253 Food law and legislation. http://id.loc.gov/authorities/subjects/sh85050300 Food Additives Legislation, Food Aliments Additifs États-Unis Congrès. Aliments Additifs Sécurité Règlements États-Unis Congrès. Aliments Additifs. Aliments Droit Législation. HEALTH & FITNESS Safety. bisacsh Food law and legislation fast Food additives fast Food additives Safety regulations fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh85050253 http://id.loc.gov/authorities/subjects/sh85050300 |
| title | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / |
| title_auth | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / |
| title_exact_search | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / |
| title_full | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / Food Forum, Food and Nutrition Board, Institute of Medicine. |
| title_fullStr | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / Food Forum, Food and Nutrition Board, Institute of Medicine. |
| title_full_unstemmed | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / Food Forum, Food and Nutrition Board, Institute of Medicine. |
| title_short | Enhancing the regulatory decision-making approval process for direct food ingredient technologies : |
| title_sort | enhancing the regulatory decision making approval process for direct food ingredient technologies workshop summary |
| title_sub | workshop summary / |
| topic | Food additives United States Congresses. Food additives Safety regulations United States Congresses. Food additives. http://id.loc.gov/authorities/subjects/sh85050253 Food law and legislation. http://id.loc.gov/authorities/subjects/sh85050300 Food Additives Legislation, Food Aliments Additifs États-Unis Congrès. Aliments Additifs Sécurité Règlements États-Unis Congrès. Aliments Additifs. Aliments Droit Législation. HEALTH & FITNESS Safety. bisacsh Food law and legislation fast Food additives fast Food additives Safety regulations fast |
| topic_facet | Food additives United States Congresses. Food additives Safety regulations United States Congresses. Food additives. Food law and legislation. Food Additives Legislation, Food United States Aliments Additifs États-Unis Congrès. Aliments Additifs Sécurité Règlements États-Unis Congrès. Aliments Additifs. Aliments Droit Législation. HEALTH & FITNESS Safety. Food law and legislation Food additives Food additives Safety regulations Conference papers and proceedings |
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